Apr 23 2010
Facet Solutions, Inc. today announced that it has finished compiling two year data from its lumbar stenosis pilot study in the US. At two years, patients in the ACADIA™ study experienced significant and sustained improvement in Oswestry Disability Index, VAS back pain and VAS leg pain. There were no re-operations in any of the patients, and all patients met the definition of success for ODI improvement.
"Treating lumbar stenosis today represents a compromise for lumbar stenosis patients," commented Dr. James Youssef of SpineColorado in Durango, CO. "With existing procedures, we can maintain motion in the segment, but must leave in at least 50% of the facets which often contributed to the problem in the first place. Alternatively, we can remove all of the pathology but must fuse the patient to re-stabilize. By contrast, using the ACADIA™ procedure, we are able to fully decompress, removing all pain generators, and implant ACADIA™ to re-establish stability and motion for the patient."
"These results represent a leap forward for treating lumbar stenosis," stated Facet Solutions' President & CEO, Geoff Pardo. "The results at one year were impressive, but the fact that they were sustained across the board at two years is particularly noteworthy." Facet Solutions, Inc. has developed ACADIA™ to provide patients with lumbar spinal stenosis and facet degeneration a motion preserving alternative to lumbar spinal fusion. The ACADIA™ procedure includes replacement of the degenerated posterior spinal joints with an anatomic implant that is designed to restore the natural motion, stability, and balance to the lumbar spine. Facet Solutions is actively enrolling its US Pivotal IDE trial at 16 centers across the United States.
Dr. James Youssef, SpineColorado in Durango, CO, will be presenting a worldwide clinical update at the upcoming Spine Arthroplasty Society meeting in New Orleans, LA on Friday, April 30th at 9:06am.
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